NCT01675869

Brief Summary

The purpose of this study is to see if an intervention training executive functions like attention, working memory, and self-regulation for preschoolers at risk for Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves attention, behavior, and functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

July 10, 2012

Last Update Submit

February 2, 2017

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention-Deficit/Hyperactivity DisorderExecutive functionPreschoolerMetacognition

Outcome Measures

Primary Outcomes (1)

  • Executive Functioning

    Investigators will compute an aggregated measure of EF deficits. For each EF measure investigators will define a threshold for adequate performance as a score obtained by 75% of the children. Performance will be dummy-coded according to this threshold as "0" for adequate performance and "1" for poor performance. We will then calculate a continuous measure of EF ranging from 0 (adequate performance on all) to 9 (poor performance on all), by summing the dummy coded scores of all EF measures.

    2 month follow-up

Study Arms (2)

ETAM group

EXPERIMENTAL

Executive Function/Metacognitive Training Program: An 8-week program, which addresses major areas of deficit in ADHD; namely, attention (the ability to concentrate and focus), inhibition (the ability to control ones behaviors), and memory (the ability to remember information).

Behavioral: Executive Training of Attention and Metacognition (ETAM)

Attention Control

ACTIVE COMPARATOR

Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc.

Behavioral: Attention Control

Interventions

Executive Training of Attention and Metacognition (ETAM)BEHAVIORAL

ETAM is an 8-week intervention involving weekly concurrent child (n=\~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).

ETAM group
Attention ControlBEHAVIORAL

Attention Control is an 8-week intervention involving weekly concurrent child (n=\~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).

Attention Control

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female, ages 3.0-4.11 years
  • Outpatients, enrolled in a structured educational setting
  • At risk for ADHD
  • Parent or teacher rated BRIEF T-score \> 60 on at least 1 subscale
  • Not in other psychosocial interventions
  • Medication free at time of the intervention
  • English-speaking

You may not qualify if:

  • Children with significant impairment will be referred for more intensive treatment.
  • Pervasive developmental disorders
  • Serious head injury or unstable medical or neurological conditions
  • Judged by one of the investigators to be acutely suicidal or homicidal, or at imminent risk of injuring self or others or causing significant damage to property
  • Children with an Intelligence Quotient (IQ) \<85 will be excluded to avoid confounds related to intellectual functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Tamm L, Epstein JN, Loren REA, Becker SP, Brenner SB, Bamberger ME, Peugh J, Halperin JM. Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits. J Clin Child Adolesc Psychol. 2019;48(sup1):S131-S145. doi: 10.1080/15374416.2016.1266645. Epub 2017 Jan 20.

    PMID: 28107027RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Leanne Tamm, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

August 30, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

US(1)